Non Invasive Imaging Methods for Detecting PA：a Clinical PET Study of 18F-Pentixather

Fangfang Sun

Status: Enrolling

Conditions: Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)

Treatments: Other: [18F]AlF-NOTA-Pentixather

Study type: Interventional

Funder types: Other

Identifiers

NCT06581744

HYX001

Details and patient eligibility

About

Primary aldosteronism (PA) is the most common endocrine cause of hypertension. 68Ga-pentixafor PET/CT possesses a relatively high sensitivity and specificity for Aldosterone producing adenoma (APA) detection. However, 68Ga is usually eluted from a 68Ge-68Ga generator, only a small amount of isotopes can be achieved once time. [18F]AlF-chelation is a promising strategy that would solve these issues. 18F labeled Pentixafor-Based Imaging Agent([18F]AlF-NOTA-Pentixather) has been reported by Andreas Poschenrieder. [18F]AlF-NOTA-Pentixather displayed high and CXCR4-specific in vivo uptake in Daudi xenografts (13.9%±0.8% injected dose per gram [ID/g] at 1 hour post injection[p.i.]). But to date 18F-Pentixather has not been studied in humans. In this program the investigators will estimate the radiation dosimetry of [18F]AlF-NOTA-Pentixather, evaluate the sensitivity and specificity of the [18F]AlF-NOTA-Pentixather as a probe for APA.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients diagnosed with primary aldosteronism and willing to undergo surgery
2. Clinically highly suspected of primary aldosteronism, but the diagnostic test cannot clearly identify the patients
3. Postoperative recurrence in patients with primary aldosteronism

Exclusion criteria

1. Pregnant and lactating women.
2. Patients with poor autonomous behavior ability, severe claustrophobia, and critically ill patients requiring life support who are unable to cooperate in completing the examination.
3. There are other situations where patients are not suitable for this examination

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

hyperaldosteronism

Experimental group

Description:

Intravenous inject 18F-Pentixather，perform PET/CT imaging at the designated time

Treatment:

Other: [18F]AlF-NOTA-Pentixather